Drug recall D-1084-2019
Product
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.
Reason for recall
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Lots and codes
Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020;
Recall details
- Recalling firm
- X-Gen Pharmaceuticals Inc., Horseheads, NY
- Quantity
- 24,966 vials
- Distribution
- Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 29, 2019
- Terminated
- June 2, 2021
Related products
- Clonidine – drug information
- NDC 39822-2000 Clonidine · Clonidine Hydrochloride 100 ug/mL · XGen Pharmaceuticals DJB, Inc.
- NDC 39822-2010 Clonidine · Clonidine Hydrochloride 500 ug/mL · XGen Pharmaceuticals DJB, Inc.